CA3141521A1 - A lyophilization process and a teverelix-tfa lyophilizate obtained thereby - Google Patents

A lyophilization process and a teverelix-tfa lyophilizate obtained thereby Download PDF

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Publication number
CA3141521A1
CA3141521A1 CA3141521A CA3141521A CA3141521A1 CA 3141521 A1 CA3141521 A1 CA 3141521A1 CA 3141521 A CA3141521 A CA 3141521A CA 3141521 A CA3141521 A CA 3141521A CA 3141521 A1 CA3141521 A1 CA 3141521A1
Authority
CA
Canada
Prior art keywords
teverelix
tfa
trifluoroacetate
molar ratio
suspension
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3141521A
Other languages
English (en)
French (fr)
Inventor
Guy Poland
Francois Boutignon
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Antev Ltd
Original Assignee
Antev Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Antev Ltd filed Critical Antev Ltd
Publication of CA3141521A1 publication Critical patent/CA3141521A1/en
Pending legal-status Critical Current

Links

Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Mechanical Engineering (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA3141521A 2018-07-05 2019-07-02 A lyophilization process and a teverelix-tfa lyophilizate obtained thereby Pending CA3141521A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18181960.8 2018-07-05
EP18181960.8A EP3590526A1 (en) 2018-07-05 2018-07-05 A lyophilization process and a teverelix-tfa lyophilizate obtained thereby
PCT/EP2019/067733 WO2020007860A1 (en) 2018-07-05 2019-07-02 A lyophilization process and a teverelix-tfa lyophilizate obtained thereby

Publications (1)

Publication Number Publication Date
CA3141521A1 true CA3141521A1 (en) 2020-01-09

Family

ID=62874674

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3141521A Pending CA3141521A1 (en) 2018-07-05 2019-07-02 A lyophilization process and a teverelix-tfa lyophilizate obtained thereby

Country Status (6)

Country Link
US (2) US11719488B2 (ja)
EP (2) EP3590526A1 (ja)
JP (1) JP7177859B2 (ja)
CN (1) CN112423776B (ja)
CA (1) CA3141521A1 (ja)
WO (1) WO2020007860A1 (ja)

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2605315B1 (fr) * 1986-10-16 1988-12-02 Rhone Poulenc Chimie Procede de preparation de trifluoroacetate d'ethyle.
US5905157A (en) * 1997-12-12 1999-05-18 Bayer Corporation Process for producing 2-(methylthio)-5-(trifluoromethyl)-1,3,4-thiadiazole using methyldithiocarbazinate and trifluoroacetic acid
DE10040700A1 (de) * 2000-08-17 2002-02-28 Asta Medica Ag Salze von biologisch aktiven Peptiden, ihre Herstellung und Verwendung
US7098305B2 (en) * 2001-09-06 2006-08-29 Ardana Bioscience Limited Sustained release of microcrystalline peptide suspensions
CN101189253A (zh) * 2004-11-12 2008-05-28 丘比斯特药物股份有限公司 抗感染脂肽类
EP1674082A1 (de) * 2004-12-22 2006-06-28 Zentaris GmbH Verfahren zur Herstellung von sterilen Suspensionen oder Lyophilisaten schwerlöslicher basischer Peptidkomplexe, diese enthaltende pharmazeutische Formulierungen sowie ihre Verwendung als Arzneimittel
US20060276626A1 (en) * 2005-05-03 2006-12-07 Avi Tovi Methods for the production of peptide derivatives
WO2008071984A1 (en) * 2006-12-13 2008-06-19 Ardana Bioscience Limited Administration of the gonadotropin-releasing hormone antagonist teverelix
EP2648755A1 (en) * 2010-12-06 2013-10-16 Astron Research Limited A stable ready-to-use cetrorelix injection
TWI580443B (zh) * 2012-06-01 2017-05-01 菲瑞茵公司 地蓋瑞利（ｄｅｇａｒｅｌｉｘ）之製備技術
CN104761632A (zh) 2015-04-14 2015-07-08 珠海联邦制药股份有限公司 一种地特胰岛素结晶的制备方法及应用
CN106279368A (zh) * 2015-05-19 2017-01-04 杭州阿德莱诺泰制药技术有限公司 一种醋酸地加瑞克制备后处理方法
CN105769774A (zh) * 2016-03-02 2016-07-20 张光泉 一种注射用醋酸地加瑞克冻干组合物及其制备方法
CN107693496A (zh) * 2017-10-23 2018-02-16 天津双硕医药科技有限公司 一种注射用地加瑞克冻干粉针及制备工艺

Also Published As

Publication number Publication date
CN112423776B (zh) 2024-05-31
EP3817760A1 (en) 2021-05-12
JP2021529166A (ja) 2021-10-28
US20210239397A1 (en) 2021-08-05
CN112423776A (zh) 2021-02-26
WO2020007860A1 (en) 2020-01-09
EP3817760B1 (en) 2022-09-07
EP3590526A1 (en) 2020-01-08
JP7177859B2 (ja) 2022-11-24
US11719488B2 (en) 2023-08-08
US20230358472A1 (en) 2023-11-09

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